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FDA Delivers OTC Monograph Facility Fees For Fiscal 2024 With Highlights On Some RSVPs

 
• By Malcolm Spicer

FDA “is highlighting” in its FY2024 facility fees announcement, and using italics for “emphasis added” for some statements, that businesses previously but no longer making hand sanitizers, though still selling the products, should contact the agency to assure they’re not assessed fees.

• Source: Shutterstock

The Food and Drug Administration could not have known, when it gained authority for OTC monograph facility fees, the lengths it would need to go to explain whether businesses are subject to the fees after unplanned and short-lived OTC production during the COVID-19 pandemic.

Three years after withdrawing before republishing its first-ever notice for the annual fees, covering fiscal year 2021, because it didn’t exclude firms that had been but no longer were making alcohol-based hand sanitizers in response to soaring pandemic-driven demand, the FDA “is highlighting” in its FY2024 facility fees announcement, and using italics for “emphasis added” for

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

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• By David Ridley

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Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 
• By Malcolm Spicer

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.